About the challenge
Lead poisoning remains a significant public health issue in the United States, disproportionately impacting children living in communities experiencing disadvantage or poverty. Even low levels of lead in blood are associated with developmental delays, difficulty learning, behavioral issues and other harmful health effects in children.
There is no safe level of lead in blood. Because clinical symptoms of lead exposure may be subtle and undetected by a clinical exam, the best way to determine exposure is to collect and test a blood sample at the point of care.
The U.S. Department of Health and Human Services’ Healthy People 2030 initiative has established goals to reduce lead exposure in the population and reduce blood lead levels in young children. New methods and emerging technologies could provide alternative diagnostic tools for public health practitioners and clinicians and help address America’s lead crisis with better testing.
By fostering and accelerating the development of innovative solutions, the Lead Detect Prize aims to enhance the detection of low levels of lead exposure through blood tests administered at the point of care. Advanced point-of-care testing solutions will enable more reliable, accessible, and efficient blood lead testing for children. The ideal solutions would be compact, easy to use, and affordable, facilitating expanded childhood lead exposure testing and early intervention.
In 2021, CDC issued new guidance for blood lead testing, decreasing the blood lead reference value from 5 μg/dL to 3.5 μg/dL. The reference value helps to determine whether medical or environmental follow-up activity is recommended for individual patients, and also helps to prioritize communities for exposure prevention efforts. Currently, there is only one commercially-available Food and Drug Administration (FDA)-cleared point-of-care test for lead in blood, and it is often unable to provide clear, actionable results at the new, lower reference value.
This updated guidance has intensified the urgent need for improved technology. In the nearly two decades since the current testing system was approved, advancements in a diverse set of scientific fields — from material science and molecular biology to microfluidics and computer science — have opened new possibilities for nearly every facet of point-of-care blood lead testing. The Lead Detect Prize invites innovators to harness new methods and emerging technologies, and turn scientific possibilities into tangible advancements for public health.
Lead Detect Prize phases
The Lead Detect Prize seeks to accelerate the development of next-generation point-of-care blood lead testing technology. By spotlighting the urgent need, providing funding and expertise, and encouraging collaboration and partnership, the challenge hopes to identify and foster new or existing breakthrough solutions and products for better lead testing in children.
Phase 1: Concepts
Phase 1 of the Lead Detect Prize invited researchers and innovators to submit technical concept papers and development plans, focusing on improving blood lead testing at the point of care, with a particular emphasis on detecting lower levels of lead exposure in children.
- Entrants submitted concept papers that described their potential solutions for improving blood lead testing at the point of care, including a scientifically rigorous rationale for success, with any applicable supporting data.
- Each submission should have included core technologies, specifications, and process descriptions; descriptions of the entrant team and expertise; and an achievable plan for prototype development, including estimated costs, critical assumptions, and risks.
- Phase 1 entrants also had access to a virtual information session and curated resources as they prepared their submissions.
- Judges will evaluate submissions according to official Phase 1 evaluation criteria. Based on their evaluation, the judges may select up to five winners. Each Phase 1 winner will receive an equal share of the $150,000 Phase 1 prize pool and receive an exclusive invitation to participate in Phase 2.
Phase 2: Development
Phase 1 winners will also be exclusively invited to enter Phase 2, which includes a virtual accelerator. Phase 2 teams will submit detailed designs and early evidence of solution performance.
- Submissions will detail systems and products, and provide evidence of functionality against target performance metrics. Submissions will also include integrated development plans to advance solutions toward the market, considering commercialization, regulation, and business viability.
- As part of the virtual accelerator, the Phase 1 winning teams participating in Phase 2 will receive access to technical webinars from subject matter experts.
- Judges will evaluate submissions according to Phase 2 evaluation criteria. Based on their evaluation, the judges may select up to three winners to receive a share of the $850,000 Phase 2 prize pool.
Phase 2 details are subject to change based on the results of Phase 1, and will be updated prior to the launch of Phase 2.